A Prospective Randomized Controlled Trial Comparing Laparoscopic Versus Endoscopic Drainage for Pseudocyst of the Pancreas
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Resolution of Pseudocyst
Study Overview
Brief Summary
This study is a randomized controlled trial comparing Laparoscopic and endoscopic drainage for pseudocyst of the pancreas secondary to acute pancreatitis. The primary outcome measure will be resolution of the pseudocyst by the intended treatment within 4 weeks. The secondary outcomes will be complications, recurrence and cost analysis between the two methods.
Detailed Description
This study will be conducted in the Department of Surgical Disciplines and Department of Gastroenterology, All India Institute of Medical Sciences, New Delhi. Patients with pancreatic pseudocyst will be randomized to two groups-
Group I- Laparoscopic management of the pseudocyst Group II- Endoscopic management of the pseudocyst
Patients will be randomized using computer generated randomized numbers in sealed envelopes to ensure concealed allocation with block randomization. The details of patients who do not meet inclusion criteria and those who refuse consent and reason for refusal of consent will also be noted. Refusal for consent for inclusion in the study will not hamper the treatment of these patients in anyway. The patients will be evaluated prospectively. CONSORT guidelines will be followed.
Preoperative Data
The details regarding demographic profile of the patient i.e. age/ sex/ body mass index (BMI) and clinical features will be noted. The duration and presenting complaint for pseudocyst and history regarding the acuteness of underlying pancreatic disease will be noted. The etiology of pancreatitis will be noted. Patients will be examined thoroughly and the characteristic features of the pseudocysts, the size and the site (head, body or tail of the pancreas) will be noted. The American Society of Anesthesiologists (ASA) grading of the patient will also be done.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 12 Years to 80 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Symptomatic patients with pseudocyst of size more than 6 cm, more than 6-8 weeks duration after an attack of acute pancreatitis.
Exclusion Criteria
- •Patients with chronic pancreatitis associated pseudocyst.
- •Patients who have undergone any form of intervention previously
- •Patients with significant co-morbidities
- •Patients unfit for general anesthesia
- •Bleeding disorders
- •Patients refusing consent
- •Patients having significant necrotic debris not considered fit for endoscopic drainage. The presence of necrotic debris will be assessed by ultrasound of the abdomen and if required magnetic resonance imaging. The volume of the cyst and that of necrotic debris will be calculated and significant debris will be defined as >30% of debris volume/volume
- •Presence of a pseudoaneurysm
Outcomes
Primary Outcomes
Resolution of Pseudocyst
Time Frame: 4 weeks
resolution on imaging
Secondary Outcomes
- Adverse Events(4 weeks)
- Cost per patient(4 weeks)
- Recurrence rate of pseudocyst(3 months)
Investigators
Dr Virinder Kumar Bansal
Additional Professor
All India Institute of Medical Sciences, New Delhi